MALARIA HRP-2 TEST, wb, 1 test (Paracheck Pf 302030025)

STD SSDTMALF25T4

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Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
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W0105090401 - Plasmodium (malaria) - rt & poc
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MALARIA HRP-2 TEST (Paracheck Pf)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 25 tests.

Definition

Immunochromatographic rapid test for the qualitative detection of Pf HRP-II (Plasmodium falciparum specific "Histidine Rich Protein-II").

HRP2 based tests are used for the diagnosis of malaria caused by P. falciparum (P. falciparum >95%).

Specifications

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Components

  • 25 pouch sealed test with dessicant and specimen transfer device
  • 1 Assay buffer bottle (total volume 4.0mL)
  • 25 alcohol swabs
  • 25 sterile lancets
  • Instructions for use
  • Bench aid

Technical specifications

  • Rapid test (± 20 minutes) in 2 steps (application blood and application of buffer solution)
  • Test performance according to "WHO Product Testing of Malaria RDTs, round 8, 2018":
    • Detection rate (200 parasites/µl, wild-type samples): 94.0 %
    • Total false positive rate: 3.4 %

Packaging & Labelling

Kit of 25 tests.

Instructions for use

Can be carried out on whole blood by capillary or venous blood collected in EDTA or heparinized tube.

Giemsa stained thick and thin blood films remain the gold standard for malaria diagnosis when possible.

This test does not provide information about total parasitemia. The test detects only infection with Plasmodium falciparum.

Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx

For offline access, contact your laboratory advisor.

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Storage

  • Store at 4-45°C
  • Shelf-life: 24 months

Waste management

Incinerate the tests and the used materials.

MSF requirements

Different tests for malaria testing are proposed in this catalogue. To decide which one to choose, please refer to your laboratory or/and malaria advisor.

Malaria tests of different brands are not interchangeable because the testing procedures are different. Before start using a new test brand read the testing procedure carefully.

High detection rate. No need for additional equipment.

Note

Due to current difficulties to procure quality-assured sources of pan pLDH tests, only HRP2 based tests or combo tests are available even for hyper- and holo-endemic areas with intense seasonal transmission. Please refer to your laboratory or/and malaria advisor to define the best option in your case.

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